Hypertension Registry of "Hypertension Prevention and Control Initiative in China"

NCT04289701 | Unknown DMC

• 1 other identifier: 2019-ZX20
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 11

Brief Summary

Hypertension is the leading preventable risk factor of cardiovascular disease globally and in China. Unparalleled to remarkable increase of hypertension burden in China, blood pressure(BP) control is inadequate. A political public health project, "Hypertension Prevention and Control Initiative in China(Chronic Disease Demonstration District Construction)", was initiated in October 2019 for explore a feasible and reproducible archetype for hypertension management and to improve the registration, management, treatment and control rates of hypertension in China. The project is designed to consecutively implement health service strategies in 40 pilot counties covering 31 provinces and around 200,000 hypertension patients in mainland China, via the National Medical Alliance for Hypertension(NMAH). The Hypertension Registry study aims to registry, follow up and observe the clinical features, treatment, blood pressure control and outcomes of all hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project.

Conditions

Hypertension

Keywords

Hypertension; Blood Pressure Control

Outcome Measures

Primary Outcomes (1)

• Change for Blood Pressure Control Rate

  Change for blood pressure(BP) control rate (number of patients under BP control divided by number of patients registered) from baseline to follow-ups. BP control is defined as follows: 1. Office BP Control: Office BP controlled to target (Systolic BP\<140mmHg and Diastolic BP\<90mmHg) 2. Home BP Control: Home BP controlled to target (Systolic BP\<135mmHg and Diastolic BP\<85 mmHg)

  at 3-month intervals over 24 months

Secondary Outcomes (4)

• Change for Systolic Blood Pressure(SBP)

  at 3-month intervals over 24 months

• Composite Outcome of Cardiovascular Events at 1-year follow-up

  1 year

• Composite Outcome of Cardiovascular Events at 2-year follow-up

  2 years

• Change for Hypertension Treatment Rate

  at 3-month intervals over 24 months

Study Arms (1)

Hypertension Cohort

Hypertension patients recruited in the "Hypertension Prevention and Control Initiative in China" project.

Other: Health Services for Systematic Hypertension Management

Interventions

Health Services for Systematic Hypertension Management OTHER

The systematic hypertension management health services from the "Hypertension prevention and control initiative in China" project. Main services are as follows: 1. Healthcare provider training and patient education. 2. Standardized guideline-based hypertension diagnosis, treatment and management recommendation. 3. Patient-centered, pan-cycle continuous hypertension management via the organizing framework of NMAH and sharing digital platform. 4. Periodical Patient follow-up via blood pressure monitor-sharing system and in collaboration with other basic local public health programs. 5. Outcome and performance evaluation quarterly. 6. Incentives for healthcare organizations and primary healthcare providers, and subsidies to patients. 7. Certification for "Honorary Hypertension Centers" at county levels and establishment for hypertension clinics at primary care centers.

Hypertension Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study recruits patients managed in the "Hypertension Prevention and Control Initiative in China" project. Eligible criteria for the registry study are equal to the inclusion and exclusion criteria for the project. All adult hypertension residents are eligible except for patients cannot be managed at local primary care centers and needing to be transferred for specialist management or residence management.

You may qualify if:

• Age ≥ 18 years.
• Residing in the local administrative area for at least 6 months.
• Hypertension：defined as systolic blood pressure (SBP) ≥140 mmHg and/or /diastolic blood pressure (DBP) ≥90 mmHg and/or use of antihypertensive medication within two weeks.
• Informed consent.

You may not qualify if:

• patients under pregnancy or lactation.
• patients with severe liver or renal diseases.
• patients with history of malignant tumor.
• patients with mental illness that impair their consent.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (11)

The First Affliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

NOT YET RECRUITING

Chinese Academy of Medical Sciences，Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Beijing Shunyi District Hospital

Beijing, Beijing Municipality, 101300, China

RECRUITING

First affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

NOT YET RECRUITING

The second affiliated hospital of Baotou medical college

Baotou, Inner Mongolia, 014030, China

NOT YET RECRUITING

The Second Affilated Hospital Of Nanchang University

Nanchang, Jiangxi, 330046, China

NOT YET RECRUITING

Yinchuan First People's Hospital

Yinchuan, Ningxia, 750010, China

NOT YET RECRUITING

First Affiliated Hospital, Xian Jiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

Teda International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

NOT YET RECRUITING

FuWai YunNan Cardiovascular Hospital

Kunming, Yunnan, 650032, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Health Services

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Jun Cai, MD,PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LUYUN FAN, MD

CONTACT

01088392165; fuwai_fanluyun@163.com

LU WANG

CONTACT

01088392165; wanglu@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director，Hypertension Center

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: October 8, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2024
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

CN (11)